Health TrialsbyHealthPanel

Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis

ConditionOsteoarthritis Thumb
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-85
SponsorDiakonhjemmet Hospital

About this trial

A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

OA confirmed by radiographs or ultrasound examination, and

Inflammation by ultrasound (grey scale synovitis grade 1-3), and

Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at rest or during activities at both pre-screening and screening.

Patient is assessed as eligible for the proposed use of Kenacort-T

Disqualifiers

Use of thumb orthosis on most of the days or structured hand exercises in the last 12 weeks

Intraarticular injections in the target CMC-1 joint in the last 12 weeks

More than 3 previous IACS in the target CMC-1 joint

Use of oral, intramuscular or intravenous steroids in the last 12 weeks

Trial design

Design model

Parallel

Treatments tested in this trial

  • Injection of triamcinolone acetonide into the CMC-1 joint

    Drug

    intraarticular injection with triamcinolone acetonide

  • Multimodal Occupational therapy for CMC-1 joint OA

    Behavioral

    Patient education, instructions about hand exercises, orthosis and training

  • Placebo

    Drug

    Intraarticular injection with saline

Treatment groups

354 Participants
are divided into 3 treatment groups
Group A: Intraarticular corticosteroid injection (IACS)Experimental treatment 1 intervention
Group B: Saline injectionPlacebo comparator 1 intervention
Group C: Occupational Therapy interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain during activities in thumb base joint

Change in thumb base joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.

Time frame
4 and 12 weeks

Secondary outcomes

1

Pain during activities in thumb base joint

Change in thumb base joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.

Time frame
All visits
2

Pain at rest in thumb base joint

Change in thumb base joint pain at rest last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.

Time frame
Week 00, 04, 12, 24, 104
3

Pain during activities in finger joints

Change in finger joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.

Time frame
Week 00, 04, 12, 24, 104
4

Pain at rest in finger joints

Change in finger joint pain in rest last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.

Time frame
Week 00, 04, 12, 24, 104

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diakonhjemmet Hospital

Lead sponsor

Vestre Viken Hospital Trust

Collaborator

Helse Stavanger HF

Collaborator

Haugesund Rheumatism Hospital

Collaborator

St. Olavs Hospital

Collaborator

Nordlandssykehuset HF

Collaborator

Source ClinicalTrials.gov
Apply now